FDA Grants Priority Review to KemPharm Pain Candidate

February 17, 2016

KemPharm has been blessed by the FDA, which has granted the company a priority review of its immediate-release hydrocodone combination product with abuse-deterrent properties.

KP201/APAP — which combines KemPharm’s prodrug of hydrocodone and acetaminophen — may limit excessive opioid exposure compared with available offerings.

In its NDA, KemPharm requested that the FDA recommend that KP201/APAP be classified as a Schedule III controlled substance, meaning it has a lower risk for abuse versus existing products. The agency has set a June 9 PDUFA date.